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临床试验/NCT02893852
NCT02893852已完成不适用

Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Changes on the Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

The purpose of this study is to investigate the effects of the Cognitive Orientation to daily daily Occupational Performance Approach (CO-OP Approach) on activity and participation in school-aged children with developmental coordination disorder (DCD).

详细描述

Children with difficulty performing activities that reflect negatively on participation can meet the criteria for Developmental Coordination Disorder (DCD), which might impact their lives, leading to social isolation, depression and anxiety. Several studies have examined the effectiveness of different intervention approaches, including process-oriented approaches that focus on enhancing body functions and structures to improve performance on functional tasks. Although pediatric occupational therapists have traditionally used such approaches, evidence strongly suggests effectiveness for task-oriented interventions that focus on the performance of tasks that the child finds difficult to do. Among these, CO-OP Approach showed strong treatment effects. In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies to improve occupational performance in goals chosen by the children. There is a need to examine systematic intervention alternatives for Brazilian children with DCD, and only one study examined occupational therapy intervention strategies for children with DCD.

The main purpose of the study is to examine the effects of two intervention models based on CO-OP Approach. The investigators will examine if a boosting on parent's engagement in CO-OP can improve skill acquisition, generalization and transfer in children with DCD. A pre-post design will be used and two groups will be included in this study (1) one receiving standard CO-OP Approach, (2) one receiving standard CO-OP Approach and an addition of coaching sessions in groups for parents. Follow-up data will be collected 3 months later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • score on MABC-2 below the 15th percentile;
  • score on DCDQ-Brazil below age expectation, indicating problems on everyday living and/or academic skills;
  • cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV);
  • no diagnosis or signs of neurological or neuromuscular diseases.

排除标准

  • no reading ability;
  • child refuses to participate on assessment sessions.

研究组 & 干预措施

standard CO-OP Approach

Active Comparator

Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents.

干预措施: standard CO-OP Approach (Behavioral)

standard CO-OP Approach plus coaching parents

Experimental

Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents with a "boost" of 4 group sessions of coaching for parents in groups.

干预措施: standard CO-OP Approach plus coaching parents (Behavioral)

结局指标

主要结局

Changes on the Canadian Occupational Performance Measure (COPM)

时间窗: Changes on perceived performance and satisfaction from baseline to 12 weeks; Changes on perceived performance and satisfaction from baseline to 24 weeks, and changes on perceived performance from post intervention to 24 weeks.

Changes on frequency on the Participation and Environment Measure -Child and Youth (PEM-CY)

时间窗: Changes on frequency levels of participation from baseline to 12 weeks; Changes on frequency levels of participation at baseline to 24 weeks, and changes on frequency levels of participation from post intervention to 24 weeks.

Changes on the Performance Quality Rating Scale (PQRS)

时间窗: Changes on actual performance from baseline to 12 weeks; Changes on actual performance from baseline to 24 weeks, and changes on actual performance from post intervention to 24 weeks.

Changes on involvement on the Participation and Environment Measure -Child and Youth (PEM-CY)

时间窗: Changes on involvement levels of participation from baseline to 12 weeks; Changes on involvement levels of participation from baseline to 24 weeks, and changes on involvement levels of participation from post intervention to 24 weeks.

次要结局

  • Changes on Five Digits Test (FDT)(Changes on Cognitive flexibility from baseline to 12 weeks.)
  • Changes on the Self-Perception Profile for children(Changes on self-perception from baseline to 12 weeks; Changes on self-perception from baseline to 24 weeks, and changes on self-perception from post intervention to 24 weeks.)
  • Changes on Tower of London Test (TOL)(Changes on mental planning from baseline to 12 weeks.)
  • Changes on Motor Assessment Battery for Children Second Edition (MABC2)(Changes on motor proficiency from baseline to 12 weeks.)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clarice Ribeiro Soares Araujo

Doctoral Candidate

Federal University of Minas Gerais

研究点 (2)

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